Why the FDA Is Bad News for Cancer Patients

One of America's foremost cancer fighters explains how the government has created a legion of "Dr. No's" who block access to innovative new drugs. People are dying not because these drugs don't exist but because they can't get them.

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Uphill struggle:Cancer patients with precious little time need answers, but the FDA restricts and obstructs research, says the former head of the National Cancer Institute.Illustration by Gwenda Kaczor

When I left the National Cancer Institute (NCI), I was proud of what I had done to reshape it into an organization capable of managing the war on cancer. But one challenge had eluded me: I was unable to persuade the administrators at the Food and Drug Administration (FDA) to change the way they reviewed new cancer drugs. What might work when it came to a new diabetes drug or a cholesterol-lowering pill did not work for cancer drugs. The FDA’s failure to recognize this was impeding our progress. And patients who could have been saved were dying.

Admittedly, the FDA has the most difficult job of all government agencies. Whatever it does, it receives a barrage of criticism. The world outside the FDA seems to be split into two groups. The first includes the many lawyers, doctors, and activists who want every aspect of our food and our drugs to be examined in fine detail before being approved so that we can eliminate as many potential risks as possible. The second group again includes lawyers, doctors, and activists, but this group holds that new drugs are too tightly regulated and that we should relax regulations so we can get potentially lifesaving drugs to patients sooner. Many members of this second group also believe that what we eat is none of the FDA’s business.

If the FDA approves drugs rapidly, it angers the first group. If the FDA approves them too slowly, it angers the second. Of course, both groups have taken things too far. Most of us recognize that we need regulations; we don’t want the FDA to go away. But we do want it to get out of the way. We need some regulations, but we don’t need all that we have now.

Here’s an example of what I mean: aspirin, one of our truly miracle drugs. In its early testing, it produced adenomas (small benign tumors) in the lungs of mice. Nothing like that has been seen in humans, but if aspirin were being developed today, the presence of adenomas might prevent the pill’s approval. Aspirin, like all drugs, has some risks, but that doesn’t mean we should take it out of patients’ hands.

The FDA has brought criticism on itself by seeking (and getting) more and more control over our lives. Twenty-five percent of every dollar we spend in the United States goes to a product regulated by the FDA. The agency has more authority and control over our lives than almost any other government agency. Yet it still wants more.

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